BIIB To Face FDA, It's A Thumb Down For REGN, STJ Meets Trial Goal

(RTTNews) - Biogen Inc.'s (BIIB) New Drug Application for Nusinersen, an investigational treatment for spinal muscular atrophy, has been accepted for priority review by the FDA. The companies have not revealed the decision date in the press release. We expect the FDA decision to be announced by April 28, 2017 because under priority review, the decision has to be announced within 6 months after the 60 day filing.

Nusinersen was licensed by Biogen from Ionis Pharmaceuticals (IONS) under an agreement signed in 2012.

IONS closed Friday's trading at $26.09, up 1.56%. BIIB closed the day's trading at $283.64, down 2.49%.

The FDA on Friday turned down Regeneron Pharmaceuticals Inc. (REGN) and Sanofi's (SNY) Biologics License Application for Sarilumab, proposed for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

In its Complete Response Letter, the U.S. regulatory agency said that certain deficiencies have been identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where Sarilumab is filled and finished, one of the last steps in the manufacturing process.

REGN closed Friday's trading at $355.83, down 2.61%.

St. Jude Medical Inc.'s (STJ) randomized trial evaluating the clinical benefits of its optical coherence tomography guidance during stent implantation has met the primary endpoint.

The trial, dubbed ILUMIEN III, was designed to compare optical coherence tomography-guided stent implantation against implantation guided by intravascular ultrasound or angiography.

According to the trial results, percutaneous coronary intervention guided by optical coherence tomography has proven to be superior to angiography in stent expansion and procedural success and non-inferior to intravascular ultrasound guided-PCI in post-procedure minimal stent area.

A global multicenter trial that will evaluate long term outcomes in patients randomized to angiography-guided PCI alone versus angiography and OCT-guided PCI, known as ILUMIEN IV study, is expected to be initiated in 2017.

STJ closed Friday's trading at $77.97, down 1.32%.